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In brief

In a statement dated 4 February 2021, the EMA announced that the Committee for Medicinal Products for Human Use (CHMP) is reviewing available data on the use of monoclonal antibodies casirivimab, imdevimab, bamlanivimab and etesevimab to treat COVID-19 patients who do not require oxygen supplementation. Recent studies have shown that the antibodies may have a greater effect when used in combination (casirivimab with imdevimab and bamlanivimab with etesevimab), which is the reason why two separated reviews are being conducted.


  • Preliminary results for both studies indicate that these combinations reduced viral load more than placebo, thus letting to fewer medical visits and hospitalizations for COVID-19. The EMA also announced that the CHMP will issue, within the shortest possible timeframe, a harmonized scientific opinion at EU level, according to which Member States can make decisions on the use of these antibodies at national level before the formal granting of marketing authorizations.

  • As regards Italy, pending the completion of the relevant marketing authorization procedures, with Decree dated February 6, 2021 the Ministry of Health authorized the distribution of monoclonal antibody-based medicinal products for the treatment of COVID-19.
Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.